Stryker Establishes an Enterprisewide Quality Management System
 
 

Stryker Establishes an Enterprisewide Quality Management System

  • Oracle Customer:  Stryker Corporation
    Location:  Kalamazoo, MI
    Industry:  Life Sciences
    Employees:  More than 20,000
    Annual Revenue:  Over $5 Billion

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Stryker Corporation is one of the world’s leading medical technology companies. Stryker’s Endoscopy division produces surgical devices for visualization and documentation systems, arthroscopy, laparoscopy, gynecology, and urology. 

 
 

 
 

Challenges

A word from Stryker Corporation

  • “Oracle’s Agile Product Lifecycle Management applications have helped us drive significant improvements in our quality management processes, and we anticipate even greater results as we continue the project rollout.” – Chris Van Wert, Director, Quality Assurance and Regulatory Affairs, Stryker Endoscopy

  • Improve enterprisewide processes required to manage the lifecycle of the company’s diverse endoscopy products and ensure their quality
  • Unify product processes across departments, from research and development, to operations, marketing, and regulatory assurance quality assurance (RAQA)
  • Simplify a cumbersome reporting process and streamline compliance with U.S. Food and Drug Administration requirements

Solutions

Oracle Product and Services

  • Implemented Oracle’s Agile Product Lifecycle Management applications to establish an enterprisewide quality management system as a single source of the truth for all product processes―increasing efficiency and data sharing
  • Deployed Agile Product Collaboration to streamline product process workflows and implemented Agile Product Quality Management as a single repository for the company’s endoscopy device quality data, facilitating regulatory compliance
  • Used product quality management tools to cut change cycle time by 50% and improve first-pass yield of change by 90%
  • Increased transparency to reduce the average number of corrective and preventive actions open at any given time by more than 40% and accelerate resolutions
  • Moved toward a closed-loop quality system, which will be complete after phase two of the implementation
  • Accelerated preparation for regulatory audits by combining events related to quality that were previously housed in different systems
  • Fulfilled corporate requests, such as providing two years of manufacturing change history data in 30 minutes
  • Benefited from Agile’s integration with the company’s Oracle enterprise resource planning system, which houses relevant information ,such as shipping data
  • Provided key metrics to drive operational improvement, with future plans to expand  report automation